Comparability of Bispectral Index and NeuroSENSE in Aged Patients

October 28, 2016 updated by: Hopital Foch

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts de Seine
      • Rueil, Hauts de Seine, France, 92500
        • Hopital Stell
      • Suresnes, Hauts de Seine, France, 92151
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Aged patients

Description

Inclusion Criteria:

  • patients older than 74 years

Exclusion Criteria:

  • pace-maker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aged patients
EEG monitoring with Bispectral Index and NeuroSENSE
Device: EEG monitoring with Bispectral Index and NeuroSENSE
Behavioral: Clinical observation
Patients will be observed during awake periods and during natural sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices
Time Frame: 1 year
Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when > 0.60%)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep
Time Frame: 1 year
Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when > 0.60%)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Julie Bresson, MD, Hôpital FOCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 13, 2013

First Posted (ESTIMATE)

December 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/36
  • 2012-A01192-41 (OTHER: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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